Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

LYPHOMED's GENERIC CEFAZOLIN IS ONE OF THREE FIRST-TIME ANDA

Executive Summary

LYPHOMED's GENERIC CEFAZOLIN IS ONE OF THREE FIRST-TIME ANDA approvals received by the firm on Nov. 17. In addition to cefazolin, (Lilly's Kefzol and SmithKline's Ancef), LyphoMed received ANDA approval for the antibiotic cephapirin (marketed by Bristol as Cefadyl) and the neuroleptic droperidol (marketed by Janssen as Inapsine). LyphoMed is the first company to receive ANDA approval for generic versions of cefazolin and cephapirin in finished dosage forms. Other companies, however, have received approval for the bulk formulations of the first-generation cephalosporins. LyphoMed's Invenex Labs division received approval for cefazolin sodium in a .5 g/10 ml vial, a 1 g/10 ml vial, a .5 g/100 ml piggyback vial, a 1 g/100 ml piggyback vial, and a 10 g pharmacy bulk package. LyphoMed said it will launch cefazolin when the patent expires in mid-1987. The Invenex division received approval for cephapirin sodium in 500 mg/ml vials; 1, 2 and 4 g/100 ml piggyback vials; and 20 g/100 ml pharmacy bulk vials. The company said a launch date has not been set. LyphoMed's droperidol approvals were for 2.5 mg/ml in 2 and 5 ml single-dose vials and, with preservative, in 2 and 10 vials. LyphoMed plans to introduce the neuroleptic in December.

You may also be interested in...



Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth

UsernamePublicRestriction

Register

SC142962

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel